BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals mixed sentiments: increased R&D expenses and operational costs are concerning, but the CardiAMP HF's potential FDA approval and competitive advantage offer optimism. The Q&A highlights slow trial enrollment and non-significant p-values, but also potential regulatory success and partnership interest. The absence of strong financial guidance and the challenge of rising costs balance the positive aspects, leading to a neutral outlook for the stock price over the next two weeks.
Key Financial Performance
Total Expense $8.3 million in 2025, increased approximately 3% year-over-year from $8.1 million in 2024. The primary driver of this change was research and development expense.
Research and Development Expense $5 million in 2025, increased 13% year-over-year from $4.4 million in 2024. The increase was primarily due to the cost of closeout activities in the cardiac heart failure trial, inception of enrollment in the CardiAMP HF II trial, and regulatory activities to advance CardiAMP in Japan.
Selling, General and Administrative Expenses $3.3 million in 2025, decreased 10% year-over-year from $3.7 million in 2024. The decrease was primarily due to lower professional fees coupled with reduced share-based compensation expense.
Net Loss $8.2 million in 2025, increased modestly from $7.9 million in 2024.
Net Cash Used in Operations $7.5 million in 2025, decreased from $7.9 million in 2024.
Cash and Cash Equivalents $2.5 million as of December 31, 2025, very comparable to $2.4 million as of December 31, 2024.
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Operating Highlights
CardiAMP Cell Therapy: Focused on treating ischemic heart failure with reduced ejection fraction. Clinical outcomes show reduced left ventricular volume disease and improved quality of life. Data from three clinical trials, including two randomized, double-blinded trials, supports its efficacy and safety. FDA and Japan PMDA discussions are ongoing for approval.
CardiALLO Allogeneic Cell Therapy: Developed for heart failure treatment. Progress has been made in clinical programs, with potential significant upside in the near term.
Helix Transendocardial Delivery System: Used in both CardiAMP and CardiALLO programs. FDA substantive feedback meeting scheduled for approval pathway.
Japan Market Expansion: Engaged with Japan's PMDA for CardiAMP approval. Formal clinical consultation scheduled to align on clinical data acceptability.
Research and Development Expenses: Increased by 13% to $5 million in 2025 due to trial closeout activities, new trial enrollments, and regulatory efforts in Japan.
Selling, General, and Administrative Expenses: Decreased by 10% to $3.3 million in 2025 due to lower professional fees and reduced share-based compensation.
Regulatory Approvals: Focused on obtaining FDA and PMDA approvals for CardiAMP and Helix systems. CardiAMP HF II trial initiated to target greatest responders and potentially serve as a post-marketing registry.
Collaborative Market Positioning: Acknowledged competitors in the ischemic heart failure space and expressed support for their efforts, indicating a collaborative approach to addressing unmet needs.
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Risk or Challenges
Regulatory Approvals: The company faces inherent uncertainties in developing new products and obtaining regulatory approvals in both the United States and Japan. Approval processes with the FDA and Japan's PMDA are ongoing, and there is no guarantee of success.
Financial Sustainability: The company reported a net loss of $8.2 million in 2025, with cash and cash equivalents totaling only $2.5 million at year-end. This raises concerns about financial sustainability and the ability to fund ongoing R&D and regulatory activities.
Market Competition: BioCardia faces competition from other companies developing allogeneic cell therapies for ischemic heart failure, some of which have already received conditional approvals or are in advanced stages of regulatory submission.
Clinical Trial Risks: The CardiAMP HF II trial is ongoing, and its outcomes are uncertain. The trial's success is critical for future approvals and commercialization.
Operational Costs: Research and development expenses increased by 13% in 2025, and further increases are anticipated in 2026. This could strain financial resources if not managed effectively.
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Guidance & Outlook
FDA CardiAMP Heart Failure Q-submission: The company is targeting submission of the Q-submission for approval pathway under breakthrough designation as soon as possible.
Japan PMDA Clinical Consultation: A formal clinical consultation is scheduled with Japan PMDA to discuss the approvability of CardiAMP cell therapy.
FDA Feedback on Helix Transendocardial Delivery System: An FDA substantive feedback meeting is scheduled to discuss the approvability of the Helix transendocardial delivery system via the de novo pathway.
CardiAMP HF II Confirmatory Clinical Study: The CardiAMP HF II study is actively enrolling patients at four centers and focuses on patients who are the greatest responders in the CardiAMP HF trial. The trial design may be modified based on FDA support for earlier approval.
EuroPCR Presentation: An abstract on CardiAMP and chronic myocardial ischemia has been accepted for oral presentation at EuroPCR in May.
R&D Expense Projections: Research and development expenses are anticipated to increase modestly in 2026 as the company advances therapeutic candidates in the United States and Japan.
SG&A Expense Projections: Selling, general, and administrative expenses are expected to remain close to 2025 levels in 2026.
Cash Burn Projections: The company expects its cash burn to remain relatively consistent in 2026, continuing its careful management of resources and capital.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide details on the p-values for diastolic and systolic volumes in the complete population from the echo data presented at THT?
A:The p-values for the complete population are not statistically significant but are approaching significance. For the subgroup with elevated NT-proBNP, the p-values are 0.02 and 0.1 for echo measures, showing large magnitude changes. This data is compelling for cardiologists and supports the narrative for regulatory discussions.
Q:What is the estimated timeline for CardiAMP submission to the FDA, and what are the potential requirements for post-marketing studies?
A:The submission for CardiAMP HF is imminent, with an estimated 45-day turnaround for FDA discussions due to its breakthrough designation. There are two approval pathways: PMDA and de novo. Post-marketing studies would involve extensive studies on hundreds of patients, collecting long-term survival, echo, and biomarker data, which can be done cost-effectively in an open-label setting.
Q:How does CardiAMP HF compare to other cell therapies for heart failure currently in regulatory discussions?
A:CardiAMP HF is seen as complementary to guideline-directed medical therapy and offers benefits in addition to it. Unlike other cell therapies that require surgical delivery, CardiAMP HF is minimally invasive and cost-effective. It has robust therapeutic data with compelling magnitude changes compared to pivotal trials for guideline-directed therapies. The competitive landscape is positive for patients, with CardiAMP HF expected to remain a leading therapy.
Q:Can you provide updates on the enrollment in the HF II trial and any challenges faced?
A:Enrollment in the HF II trial is starting slowly due to the clinical team's focus on regulatory submissions for the Phase III trial data. The trial's future depends on discussions with PMDA and FDA, which will determine if it remains a randomized trial or transitions to an open-label post-marketing study. Many sites are interested, but resource constraints have slowed progress.
Q:What should we expect from the 6-month data for the CMI trial at EuroPCR in Paris?
A:The 6-month data will provide more visibility into the physician and patient experience. The CMI trial is currently paused to focus on the heart failure program, but it doubles the market potential of CardiAMP HF. Advancing the CMI trial depends on resource availability and business development discussions.
Q:How would you characterize the environment for potential partnerships?
A:The environment for partnerships is evolving, with interest expected to grow as CardiAMP HF progresses toward potential early approval in the U.S. or Japan. The recent approval of a cardiac cell therapy in Japan may also drive interest in CardiAMP HF and CMI.
Q:Review of Unclear Management Responses
A:Management avoided providing specific enrollment numbers for the HF II trial, citing resource constraints and ongoing regulatory discussions as reasons for the slow progress. Additionally, they did not provide detailed updates on the business development environment, offering only general comments about evolving interest.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
CD
CardiAMP HF
CardiAMP cell
CardiAMP system
Cardiac
Devices
FDA CardiAMP
FDA Center
HF II
HF trial
Health
University
approvability CardiAMP
approval cell
biomarkers heart
cardiac event
control
disease heart
ejection fraction
end volume
failure ejection
fraction patient
heart stress
milliliter meter
patient biomarkers
reduction
respect safety
safety efficacy
study
subgroup patient
suppression remodeling
therapy program
trial CardiAMP
BCDA Transcript
BioCardia, Inc. (BCDA) Q4 2025 Earnings Call Transcript
Unknown3-24
The earnings call reveals mixed sentiments: increased R&D expenses and operational costs are concerning, but the CardiAMP HF's potential FDA approval and competitive advantage offer optimism. The Q&A highlights slow trial enrollment and non-significant p-values, but also potential regulatory success and partnership interest. The absence of strong financial guidance and the challenge of rising costs balance the positive aspects, leading to a neutral outlook for the stock price over the next two weeks.
BioCardia, Inc. (BCDA) Q3 2025 Earnings Call Transcript
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The earnings call shows mixed signals: a slight increase in revenue, reduced SG&A expenses, and a decrease in net loss for Q3, but an increase in net loss over nine months. The Q&A reveals positive progress in trials but lacks transparency in patient enrollment numbers. The strategic plan highlights potential partnerships and regulatory approvals, which could be positive. However, the absence of market cap data and the lack of immediate strong catalysts lead to a neutral outlook for short-term stock movement.
BioCardia, Inc. (BCDA) Q2 2025 Earnings Call Transcript
Unknown8-11
The earnings call reveals mixed signals. Financial performance shows increased net loss and cash usage, which are negative. However, there are ongoing advancements in trials and partnerships, which are positive. The Q&A highlights uncertainties around regulatory approvals and partnerships, but also potential growth opportunities. The neutral sentiment reflects this balance of positive developments against financial challenges and uncertainties.
Earnings call transcript: BioCardia’s Q1 2025 results show clinical progress
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The earnings call reveals financial challenges, including a significant net loss, increased expenses, and a low cash position. While there are potential partnerships and regulatory progress, the failure to meet primary endpoints in trials and competitive market pressures raise concerns. The Q&A session shows management's vague responses on key issues, adding to uncertainty. Despite some positive aspects, such as modest financing and ongoing trials, the overall sentiment is negative due to financial instability and regulatory risks.
BCDA Report
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